Acute Liver Failure

Acute liver failure and acute liver injury observational study

Enrollment status: OPEN

A multi-center NIH study initiated in 1997 is looking at acute liver failure and severe acute liver injury in adults. The aim of this study is to gather prospective demographic and clinical data on patients with acute liver failure and acute liver injury with varying etiologies.

Inclusion criteria

• INR > 1.5 with or without encephalopathy due to any cause

Informed consent may be obtained from family member.

Blood and urine samples, clinical data, and survival will be obtained x 7 days.

Patients are invited for a return visit at 6 and 12 months to assess long-term outcomes. Participants will receive $30 for each return visit.

Contacts for referrals or questions: see below

STOP-ALF: A phase 2a study to evaluate the safety and tolerability of OCR-002 (ornithine phenylacetate) in the treatment of patients with acute liver failure/severe acute liver injury due to acetaminophen overdose

Enrollment status: OPEN

The goal of the STOP-ALF protocol is to evaluate the safety and tolerability of OCR-002 (ornithine phenylacetate) to reduce venous ammonia levels in patients with ALF or severe liver injury due to acetaminophen overdose.

Inclusion Criteria

• ALF or ALI (INR ≥ 1.5) secondary to acetaminophen overdose
• Venous ammonia ≥ 60 µmol/L

Study design

• Continuous infusion of OCR-002 (ornithine phenylacetate) for 5 days
• Collection of blood samples, urine, and EKGs throughout the study
• Follow-up visit at 1 month (participants will receive $30 for participation in the follow-up visit)

Contacts for referrals or questions

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu

• Sophana Mao, BS (734) 936-4886 skmao@med.umich.edu